Porifera-based therapeutic compositions for treating and preventing skin diseases

ABSTRACT

Therapeutic compositions and methods for using same for treating skin conditions and diseases are disclosed. Treatable skin conditions and diseases include without limitation acne vulgaris, rosacea, seborrheic dermatitis, eczema (atopic dermatitis), psoriasis, photo-aging and actinic keratosisacne vulgaris, psoriasis, photo-aging and eczema. Therapeutic compositions disclosed are derived from Porifera species, specifically sponges, and more specifically fresh water sponges. One disclosed embodiment is derived from Spongilla species and is formulated with pharmaceutically acceptable excipients.

RELATED APPLICATION

[0001] The present application is a continuation-in-part of U.S. patentapplication Ser. No. 10/186,996 filed Jul. 1, 2002 which is herebyincorporated by reference.

FIELD OF THE INVENTION

[0002] The present invention is directed to therapeutic compositionssuitable for treating skin diseases. Specifically, the therapeuticcompositions of the present invention are derived from the Eukayotephylum Porifera. The therapeutic compositions of the present inventioncan be applied topically for the treatment of various skin disorders anddiseases.

BACKGROUND OF THE INVENTION

[0003] Skin diseases remain a significant medical and social problemthroughout the world. The most common, and therefore the mostsignificant skin diseases, include acne vulgaris, rosacea, seborrheicdermatitis, eczema (atopic dermatitis), psoriasis, photo-aging andactinic keratosis. These skin diseases combine to account for billionsof dollars in medical treatments and untold emotional suffering. Theemotional impact of skin disease is particularly relevant becausepatients become easy prey for unscrupulous practitioners and treatmentregimes of questionable efficacy. Over the last one hundred yearssignificant advances in pharmaceuticals and dermatological procedureshave greatly reduced the severity and frequency of skin diseases.However, many patients do not comply with the often complex and tedioustreatment protocols their practitioners prescribe. Moreover, thelong-term use of antibiotics has resulted in increased microbialresistance of the bacteria responsible for various skin diseases.Additionally, other chemotherapies can be extremely toxic and have longterm deleterious effects on the patient's health and skin. Therefore,alternative therapies for treating skin disorders that are safe,effective and easy to use are urgently needed.

[0004] Acne vulgaris is the most common of all skin disorders thataffects 85% of teenagers. Nearly 80 percent of the population experienceacne at some point in their lives. Moreover, in addition to being aserious medical condition, acne inflicts a heavy emotional andpsychological burden on its victims. Marion Sulzberger, Md., one of thefounding figures of modern dermatology, wrote in 1948 “there is nosingle disease which causes more psychic trauma, nor maladjustmentbetween parents and children, more general insecurity and feelings ofinferiority and general sums of psychic suffering than does acnevulgaris.” The impact can be devastating, leading to depression and evento thoughts of suicide. A survey of 1,985 people by the ASG revealedthat three out of four people with acne felt depressed and almost halffelt anxious. Research by William Cunliffe, Md., in the United Kingdom,showed that patients with acne had a higher unemployment rate than age-and sex-matched controls. More than a third felt they would have abetter job if they didn't have acne, the survey revealed.

[0005] Acne is a chronic disease involving the pilosebaceous follicles.Sebaceous glands are found most abundantly on the face and scalp, thoughthey are present on every part of the skin except the palms of the handsand soles of the feet. Cutaneous disorders attributed to the sebaceousgland are really disorders of the entire pilosebaceous unit. The areasmost commonly involved in acne are the face, upper chest, and back.Other less common areas include the upper arms, buttocks, and upperthighs.

[0006] Acne vulgaris evolves within the pilosebaceous unit via amultifactorial pathogenesis. The central pathogenic factors in acneinclude excessive sebum production secondary to androgen stimulation,outlet obstruction of the sebaceous follicle arising from excessproduction of keratinocytes (the basic cell of the epidermis),proliferation of Propionibacterium acnes and inflammation followingchemotaxis and the release of various proinflammatory mediators.

[0007] During the prepubertal period the increase in adrenal androgenstriggers the enlargement of the sebaceous glands. These enlargedsebaceous glands produce increased amounts of sebum, which flows throughthe canal of the sebaceous follicle. This canal is lined with akeratinizing epithelium. In acne patients, there is increased productionof the follicular comeocytes lining the follicle and retention of thesecorneocytes within the follicle. The abnormally desquamated corneocytesand the excess sebum build up within the follicle to form a microscopic,bulging mass. This enclosed, sebum-rich environment is ideal for theproliferation of P. acnes, the anaerobic bacterium that produceschemotactic factors and recruits proinflammatory molecules involved inthe inflammatory phase of acne. Obstruction of the sebaceous follicle,the primary pathologic event in acne, is giving rise to themicro-comedo, the precursor of all acne lesions. It is a microscopic,bulging mass that results from a combination of hyperproliferativecorneocytes and sebum and leads to follicular plugging.

[0008] Once the follicle is plugged, its lower portion becomes engorgedand distended with sebaceous discharge and keratinocytes. While the poreopening remains closed, the lesion is called a closed comedo, or“whitehead.”. It is a noninflammatory lesion that evolves from themicrocomedo and appears as a white dot ranging from 0.1 to 3.0 mm indiameter and very slightly raised.

[0009] Oxidization occurs when the follicle enlarges enough to stretchthe pore and the trapped matter is exposed to air. This causes thecharacteristic dark appearance of open comedones or “blackheads.” Opencomedone is a noninflammatory lesion that appears as flat or slightlyraised, brown-to-black color, about 3-5 mm in diameter.

[0010] Early acne, involving a majority of open and closed comedones, isa noninflammatory process. As dilation of the follicle continues, thefollicular epithelium is disrupted and irritants such as sebum, hair,and keratinocytes are released into the surrounding dermis. This leakagecauses an inflammatory reaction and initiates the formation of theinflammatory lesion papules, pustules, and nodules. Although P. acnes isa live bacterium, living in the follicle, it dies when the follicularstructure is disrupted. Toxins are released into the dermis, whichincreases inflammation. Therefore, uncomplicated, inflammatory acne is asterile process and not a skin infection. As inflammation continues toworsen, larger papules and pustules are created. A papule is apink-to-red, raised, palpable lesion with no visible accumulation offluid, which can range from 1 to 4 mm in diameter.

[0011] A pustule is a raised accumulation of purulent material on theskin's surface, and is similar in size to the papule. Pustules aresometimes characterized as superficial or deep. In a superficial pustulethere is a localized rupture of the epithelium near the skin surface,and in a deep pustule there is extensive destruction of the entireepithelium. Acne nodules are solid, raised inflammatory lesions thatexceed 6-10 mm in diameter and are situated deeper in the dermis. Anodule may persist for weeks. The acne cyst is a large nodule (may be aslarge as several centimeters in diameter) that has suppurated and becomefluctuant. Scars form as a result of damage to the surrounding dermis.Scars may appear as small deep punched out pits (“ice pick”), atrophicmacules, hypertrophic papules, or broad, sloping depressions. Darklypigmented skin affected by acne tends to develop significantpostinflammatory hyperpigmentation. This tendency has given rise to thesuggestion that a new acne lesion should be designated—the acnehyperpigmented macule (AHM). The AHM can last for four months or longer,and is often the central complaint of acne patients with skin of color.

[0012] There is no single standardized grading system for acne, butthere are several useful methods used to classify the disease. Mostsimply, acne is described as mild, moderate, or severe. Because acne isa chronic, emotionally stressful condition that may persist for years,long term therapy is often required. Presently the clinician hasnumerous treatment options. However, each one has significant adversequalities and varying degrees of efficacy.

[0013] The most commonly used nonprescription topical product is benzoylperoxide. Benzoyl peroxide (BP) is an antimicrobial that is effectivefor killing P acnes. It usually takes about two weeks to work and itmust be used continuously to keep acne at bay. This is because BP doesnot affect microcomedo formation, sebum production or the way the skinfollicle cells are shed, and when patients stop using it, the acne comesback. Benzoyl peroxide is marketed under a variety of trade names inover 200 formulations, including gels, creams, lotions, washes, and barsoaps, in a variety of concentrations (most often 2.5%, 5%, and 10%). Ifused continuously, it often improves condition for milder cases of acne.Concentration should be chosen accordingly to skin type and tolerance.Side effects consist mainly of skin irritation including burning,blistering, crusting, itching, severe erythema, skin rash, dryness, andchemical imbalance of the skin. Benzoyl peroxide further reduces skinlevels of superoxide dismutase, catalase and other skin antioxidantsthat are important in preventing and healing acne. Moreover, bydestroying anti-oxidants naturally occurring in the skin Benzoylperoxide promotes premature aging of the skin.

[0014] Another nonprescription topical treatment is salicylic acid.Salicylic acid helps to correct the abnormal shedding of cells and isuseful in treating milder acne. Salicylic acid helps unclog pores toresolve and prevent lesions. However, salicylic acid does not inhibitsebum production or possess antimicrobial properties. The patient mustuse salicylic acid on a regular basis to prevent acne from returning.Salicylic acid is available in many acne products, including lotions,creams, washes, gels, and pads.

[0015] In many cases over-the-counter (OTC) preparations are noteffective and must be used in combination with prescription drugs.Antibiotics are the most commonly prescribed class of anti-acnemedications. Antibiotics work inhibiting the growth of P. acnes and maybe applied topically or taken systemically. The most widely prescribedtopical antibiotics are erythromycin and clindamycin. Topicalantibiotics are limited in their ability to penetrate the skin and clearmore deep-seated P. acnes and do not inhibit comedo formation alone andthus must be used in combination therapies.

[0016] Systemic antibiotics circulate throughout the body and intosebaceous glands. Systemic antibiotics are used to treat severe acne butgenerally have more side effects than topically applied medications.They also do not address the other causative factors in acne and maytake several weeks or months to clear up acne. Oral antibiotics areusually used in combination with other drugs that “unclog” folliclessuch as salicylic acid. However, systemic antibiotic therapy isincompatible with pregnancy and some may reduce the effectiveness oforal contraception pills, risking a pregnancy during treatment.

[0017] The front-line oral antibiotics for the treatment of acne are thetetracyclines. Tetracycline cannot be taken with food containingdivalent cations such as calcium and iron and predispose patient tosevere sunburn or a pruritic rash due to its photosynthesizingqualities. All tetracyclines are contraindicated in pregnancy and inchildren who have not yet formed their permanent teeth (risk ofdiscoloration). Additionally tetracycline call antibiotics often causeesophageal irritation. Side effects of minocycline (a commonlyprescribed synthetic tetracycline) may include vertigo, blue-graydiscoloration of the skin and teeth, and a lupus-like syndrome.

[0018] Erythromycin has long been considered the preferred second-lineoral antibiotic for acne therapy. It does have an excellent side-effectprofile (with gastrointestinal upset generally the most common problem)and may be approved for use even in pregnant women. However,antimicrobial resistance is a major problem associated with allantibiotics commonly used to treat acne and this is most pronounced witherythromycin. The emergence of antibiotic-resistant P. acnes is an issueof increasing concern with both topical and oral antibiotics in thetreatment of acne. Over the past 25 years, laboratory studies havedemonstrated a rapidly increasing pattern of P. acnes resistance toantibiotics, especially erythromycin (published studies indicate thatthe overall incidence of antibiotic-resistant P. acnes has increasedfrom 20% in 1978 to 62% in 1996). Bacterial resistance is diminishingthe effectiveness of current acne therapies and threatens to limit theoptions available to heal the most common skin condition diagnosed andtreated by physicians. Antibiotic resistance in acne treatment is aglobal problem as antibiotic-resistant strains of P. acnes have beenreported in the United Kingdom, Germany, France, Japan, and the UnitedStates.

[0019] Vitamin A derivatives or “retinoids” are being used withincreased frequency as topical treatments for moderate to severe acne.The topical retinoids include vitamin A acid (tretinoin), its analogs,and newer agents that bind to and activate retinoid receptors. Topicalretinoid preparations help to unclog pores and normalize skin growth andshedding. However, topical retinoids can cause severe skin irritationand therefore require titration at the initiation of therapy to allowpatients to adjust. Moreover, topical retinoids and retinoid analogspose a risk of teratogenicity. For example, Tazarotene is a pregnancycategory X drug and should not be used in pregnant women.

[0020] Recently, the FDA has approved the oral retinoid Isotretinoin(Accutane). Accutane is recommended for patients who have severescarring and cystic acne. Accutane is anti-inflammatory and decreasesthe size of the sebaceous glands, thus decreasing the amount of sebumproduced and causes long-term acne remission and reduces scarring.Accutane is treatment is indicated if less than 50% improvement in acneseverity is observed after 6 months of treatment with combinationtopical and oral therapy, the appearance of scar, acne that isassociated with significant psychological distress or acne that quicklyrelapses during or shortly after conventional therapy. However, Accutanehas many adverse reactions, including hepatotoxicity, increased levelsof triglycerides, pancreatitis, and hypercalcemia with loss of bonemass. Moreover, Accutane is teratogenic. Consequently, the FDA mandatedthat women undergoing Accutane therapy must use two forms of birthcontrol. Moreover, recently Accutane has been linked to depression andsuicide. Parents are required to sign a consent form asserting theirunderstanding of this possibility and should be cautioned to carefullymonitor the emotional status of teens being treated with Accutane.

[0021] Anti-inflammatory medications called corticosteroids may beinjected by a dermatologist directly into severe inflamed acne lesionsto help heal existing lesions. However, these do not prevent developmentof new acne and may leave a permanent hardening in the place ofinjection.

[0022] Acne vulgaris is a chronic dermatologic disorder that must betreated consistently. It is not unusual that traditional topical therapywill initially worsen acne due to irritating, sensitizing, and toxicproperties of the chemical therapeutic agents. This initial responseusually lasts 2 to 4 weeks. Since it takes about 28 days to regenerateskin, the effect of medications does not appear immediately.Improvement, if any, becomes noticeable after 4 to 8 weeks of therapy.The maximum benefit of systemic agents, such as oral contraceptives, onacne occurs not earlier than in 34 months.

[0023] Many OTC preparations are toxic for the skin enzymes, which makesthem automatically toxic for the skin overall. Intracellular andextracellular enzymes that found in the skin are essential for healthyskin condition, right pH and skin protective capability againstpathogens. The consequences of an impairment of enzymes, even throughthe inactivation of trace elements that primary act for enzymeperformance, cannot be evidence after one or a few applications but onlyfollowing repeated treatments, for example as in the case with BenzoylPeroxide preparations for acne prone skin, which might be appliedseveral times a day for many years.

[0024] A non-compliance with anti-acne regime is one of the majorreasons for treatment failure among patients with acne vulgaris.Motivating patients to adhere to treatment, especially during themaintenance phase, remains a challenge. A recent randomized, controlledstudy involving young adults with acne vulgaris evaluated the efficacyof various non-pharmacologic interventions for enhancing adherence tobenzoyl peroxide. Adherence was measured through a combination ofpatient self-report and the return of self-monitoring cards. The overalladherence rate after 3 months was 48%. The study found that 52% ofpatients were noncompliant. They did not exactly follow the directivesof their dermatologists due to the complexity of the regime.

[0025] Both researchers and practicing clinicians concur that thesimpler the medication regimen for acne patients, the better theadherence. To improve the compliance among this group of the patients,effective, well tolerated, and simplified regime is needed.

[0026] Although acne is the most common skin disease and one with thegreatest economical and sociological significance, it is not the onlyskin disorder that can benefit from improved therapeutic regimes andcompositions. For example rosacea, seborrheic dermatitis, eczema (atopicdermatitis), psoriasis, photo-aging, actinic keratosis, and great numberof other bacterial, viral, and fungal diseases as well as skinpigmentation disorders are also significant health and cosmetic problemsrequiring improved therapies with simplified regimes.

[0027] The Holy Grail of medicine would be to slow or reverse the agingprocess. Aging is a complex process that is largely determinedgenetically. However, free radical damage caused by reactive oxygenspecies contributes significantly to the aging process. Onemanifestation of free radical-associated aging are so-called “agespots.” Age spots are actually the accumulation of special pigmentscalled lipofuscin, a brown waste, that accumulates in the skin in highlydamaged areas.

[0028] Protection against free radical-associated oxidative damageincludes the activation of water-soluble reductants in the cytosol,lipid-soluble antioxidants residing in cellular membranes, and theantioxidant enzymes, superoxide dismutase, catalase, ascorbateperoxidase, glutathione peroxidase and glutathione reductase. Biogenicproduction of free radicals occurs mostly during normal processes ofcellular metabolism. A by-product of energy metabolism is the uncouplingof electrons in the transport chain to generate superoxide, viaactivation of molecular oxygen, leading to the production of hydrogenperoxide and the supra-reactive hydroxyl radical. Such reactive oxygenspecies (ROS) are highly damaging to DNA, proteins and membrane lipidscausing cellular impairment. In the normal condition of aging,antioxidant functions decline to further accelerate the aging process,and this exacerbates the progression of age-related degenerativediseases. Therefore, preventing or decreasing the formation of reactiveoxidants in metabolic electron transport presents a clear strategy forreducing cellular oxidative stress and rate of aging.

[0029] Free radical damage has also been implicated as a cause, orexacerbating factor in eczema. A recent university sponsored studyexamined the levels of lipid peroxidation in erythrocytes, someparameters of the antioxidant system and the activity of lysosomalenzymes in eczema patients of mix origin (exo/endogenous). The resultsof the study reveal an intensification of erythrocyte lipid peroxidationand a depression of antioxidant protection. This imbalance of lipidperoxidation/antioxidant systems induces modifications in biomembrane'sstructure, especially lysosomal ones. That follows to an increase of thelysosomal intracellular activity and then to a lysosomal penetration inblood circulation and facilitates cutaneous inflammatory manifestations.So, the complex treatment of eczema must include an antioxidant therapyand a pharmacological stabilization of lysosomal membranes.

[0030] The Department of Dermatology and Skin Ageing, and CancerResearch Centre of University Pavia in Italy studied the activity of 14enzymes, representative of the main metabolic pathways in epidermis of63 normal human subjects ranging in age from 1 month to 90 years. Nodifference of activity was observed in any of the enzymes studieddespite the varied age. The lack of influence of age on the activity ofthe enzymes in human epidermis enhances the significance of thevariations, which are reported in pathological conditions likepsoriasis, chronic sun-damaged skin and neoplasm.

[0031] In addition, enzyme activity depression in chronicallysun-exposed skin has a significantly contributes to neoplasm formation.This is clearly evidenced by the fact that the areas usually exposed tothe sun's rays (e.g., face, back of hands) are 100 times higher than onthe skin of unexposed areas (e.g., abdomen). This leads one to regardchronic sun damage as a precancerous state. Chronic exposure toultraviolet (UV) light is the leading cause of extrinsic aging, oralterations of the skin due to environmental exposure. Estimatesindicate that almost half of a person's UV exposure occurs by age 18.Photo aging causes numerous histological, physiologic, biochemical andclinical changes.

[0032] One of the manifestation of aging skin is decreased ability toshed dead cells, resulting in various unsightly skin conditions. Themainstay of topical therapy of photo-aging skin continues to be chemicalpeels. A chemical peel is a procedure in which a topically appliedwounding agent creates smooth, rejuvenated skin by way of an organizedrepair process. Complications of chemical resurfacing, includingpermanent sequelae, such as pigmentary dyschromias, infection, orscarring, may occur even though a controlled chemical wound induced.

[0033] Therefore, there remains a need for therapeutic topicalcompositions that are safe, effective, possess multifaceted mechanismsof action and are conducive to patient compliance.

SUMMARY OF THE INVENTION

[0034] The present invention relates to novel skin care therapeuticsderived from invertebrate species of the phylum Porifera. Poriferans arecommonly referred to as sponges. An early branching event in the historyof animals separated the sponges from other metazoans. Fossil spongesdate from the late Precambrian period are among the oldest known animalsand account for over 900 fossil genera. The approximately 5,000 livingsponge species are classified in the phylum Porifera, which is composedof three distinct groups, the Hexactinellida (glass sponges), theDemospongia, and the Calcarea (calcareous sponges).

[0035] The skin care therapeutic compositions of the present inventionare useful in treating and preventing a wide variety of skin conditionsincluding, but not limited to, acne vulgaris, rosacea, seborrheicdermatitis, eczema (atopic dermatitis), psoriasis, photo-aging andactinic keratosis. Moreover, the skin care therapeutics of the presentinvention are useful as skin resurfacing compositions, treatments foroily skin, and as deep peeling treatments. In an exemplary embodimentthe compositions of the present invention are applied topically. Thetopical applications can be applied monthly, weekly, daily or multipletimes daily depending on the condition to be treated and extent ofdisease progression. Moreover, the compositions of the present inventioncan be applied in combination with other topical or systemic therapies.

[0036] In one embodiment of the present invention the skin caretherapeutics are derived from the Porifera Subphylum Cellularia, ClassDemospongiae, Subclass Ceractinomorpha, Order Haploscierida FamilySpongillidae Genus Spongilla.

[0037] In one embodiment of the present invention the Porifera isharvested from marine water sources including but not limited to saltwater lakes, oceans and inland seas.

[0038] In another embodiment of the present invention the Porifera isharvested from fresh sources such as rivers, lakes, ponds and streams.

[0039] In yet another embodiment of the fresh water source is located inEurasia, specifically the Russian Federation.

[0040] In another embodiment of the present invention a topical skincare therapeutic is made from powdered Spongilla.

[0041] In yet another embodiment of the present invention a topical skincare therapeutic is made from powdered fresh water sponges selected fromthe group consisting Spongilla lacustris L., Spongilla. fragilis Leidy,and Ephydatia fluviatilis.

[0042] In another embodiment of the present invention the powderedSpongilla is compounded with other active and inactive ingredients.Ingredients include, but are not limited to antibiotics,anti-inflammatories, antiseptics (such as, but not limited to, hydrogenperoxide and boric acid), anesthetics, coral powder, white seaweedpowder, green seaweed powder, enzyme gel, jojoba oil. The Spongillapowder is present in the amount of from approximately 0.1% to 100%Spongilla powder.

[0043] In another embodiment of the present invention the inactiveingredients include water selected from the group consisting of waterfor injection, distilled water, deionized water, chamomile water andcalendula water.

[0044] In another embodiment of the present invention the inactiveingredients includes pharmaceutically acceptable diluents, fragrance,coloring and emollients.

[0045] In yet another embodiment of the present invention thetherapeutic composition comprises from 1 to 1.5 grams of substantiallypure Spongilla powder, and at least one additional excipient selectedfrom the group consisting of from 0.1 to 0.5 grams of green seaweedpowder, from 0.1 to 0.5 grams of white seaweed powder, from 0.1 to 5grams of 0.2 grams of coral powder, from 0.5 mL to 5 mL of 0.1% to 10%hydrogen peroxide, from 0.5 mL to 5 mL of 0.1% to 10% boric acid andfrom 0.5 to 10 mL of water.

[0046] Other embodiments and characteristics of the invention willappear in the course of the description and examples that follow.

BRIEF DESCRIPTION OF THE FIGURES

[0047]FIG. 1 depicts a specific geographical location where one speciesof the Porifera of the present invention can be harvested.

[0048]FIG. 2 depicts a patient before receiving treatment for acne inaccordance with the teachings of the present invention

[0049]FIG. 3 depicts the patient in FIG. 2 after receiving treatment foracne in accordance with the teachings of the present invention

DETAILED DESCRIPTION OF THE INVENTION

[0050] Natural Marine Products are relatively new and have become aactive area of research for new industrial chemicals, biologics andchemotherapeutics. Natural Marine Products Chemistry is a critical partof this research and is responsible for the isolation and Identificationof the vast array of novel molecules produced by marine organisms. Manyof these molecules possess structural features that are unique to marineorganisms and result from the unique aquatic environment (high level ofhalogens and nitrogen) in which the host organisms live. There ismounting evidence that many of the natural products isolated from marineorganisms may be derived from symbiotic microorganisms residing withinthe marine organisms.

[0051] Biologically active metabolites are produced by organisms for arange of purposes including relief from environmental stress, chemicalsignaling, and aggression among species. These natural processes caninform the search for functional bio molecules directed towards specificapplications. For example, new sunscreen products were discoveredthrough basic research into the tolerance of reef corals to ultra-violetradiation.

[0052] Sponges are multicellular marine animals belonging to a largegroup of simple animal species known as invertebrates. Spongesoriginated billions of years ago and are among the oldest animals onearth. Presently, approximately 5,000 species of Sponges are known.Sponges are composed of a soft tissue suspended in a jelly-likeproteinaceous matrix supported by a hard skeleton composed ofneedle-like structures known as spicules. Spicules are primarilycomposed of calcium carbonate, or silica and collagen.

[0053] Sponges belong to phylum Porifera, a highly primitive group withno tissue grade of organization. The stiff body houses numerous channelsand pores allowing currents of fresh water to enter. The largest incurrent pores are known as oscula, and the smallest are ostia.Food-bearing water flows into the sponge through the ostia in itsmound-like body and out through osculum. Water is encouraged to flowwithin the sponge by the action of flagellated choanocytes. Choanocytesalso constitute the filter-feeding apparatus, trapping suspended foodparticles as they pass along the series of internal channels. Becausesponges are essentially sessile, they are heavily reliant upon theeffectiveness of their cell-lined channels in trapping food, oxygenuptake and removal of waste products. Sponges are highly susceptible topollution and release of suspended sediments which block up theirdelicate system of tubes and pores, thus preventing basic bodyfunctions. Sponges have great powers of regeneration from injury orpredation.

[0054] Two reproductive processes are known to occur in the sponges: theone of them, asexual, and the other, truly sexual. In the commonfresh-water Sponges, towards the autumn, the deeper layer of the spongebecomes full of exceedingly small bodies, sometimes called “seeds” or“gemmules.” The whole Sponge dies down, and the seeds, enclosed in theircase, remain uninjured through the winter. At the springtime, theencysted masses of sponge particles stimulated by the alteredtemperature of the water, creep out of their “seeds”, and grow up intoSponge.

[0055] The success rate of finding a new active chemical in marineorganisms is 500 times higher than from terrestrial sources. Spongeshave proven to be a prolific source of novel therapeutic agents, oftenwith biomedical action superior to that of existing pharmaceuticals.Drug discovery from sponge colonies is now a major focus of thepharmaceutical and biotechnology industries. However, the primary areaof concern about this new source of therapeutics is the question oftheir supply and difficulties of culturing sponges and their symbiontsin the lab. The reliability and reproducibility of material from naturalsources is also critical, because seasonal and environmental changesinterfere with the chemical composition and biological properties ofnatural samples. Furthermore, biologically active molecules are expectedto be produced only temporarily as a response of specific environmentalstress. Extracting sufficient quantities of the active chemical from thenatural source just for completion one clinical study requires many tonsof sponge colonies and as a result is not a viable option for worldwidedistribution. Therefore, while marine biotechnology presents tremendouspotential for new pharmaceuticals, commercial success is minimal tonone.

[0056] Nevertheless, like many natural products, sponges have been usedin homeopathy and other forms of natural medicine for centuries. EasternEurope and Eurasia have a long history of preparing tinctures andpowders from aquatic animals including fresh water sponges. Folkmedicines known collectively as “Bardiaga” refer to powdered fresh watersponges and used for medicinal purposes. Russian folklore andhomeopathic teachings suggest that Bardiaga is useful for treating suchdiverse syndromes as bruising arthritis and rheumatism.

[0057] Bath sponges (Spongia officinalis) have also been used forcenturies for cleaning wounds, for contraception and even as implantsafter breast cancer operations. Furthermore, folk medicine and naturalmedicine literature is replete with diverse preparations made from driedsponges and used to treat and palliate myriad diseases. The oldestmedicinal sponge preparation in recorded history is dried and burned S.officinalis is offered as a treatment for goiter and thyroid-relateddiseases. The unusually high concentration of iodine in S. officinalismade is a uniquely effective folk remedy.

[0058] Since sponges are essentially non-motile animals that are highlysusceptible to predators and changes in their microenvironments, theyhave evolved an elaborate bio-defense system that includes a cornucopiaof biologically active (bioactive) compounds. Today, it is believed thatmany of these sponge-derived bioactive compounds possess cytotoxic,antibiotic, anti-viral, anti-inflammatory, and anti-fouling properties.However, most of these bioactive compounds remain uncharacterized.Furthermore, as discussed above, these bioactive compounds are producedin extremely low concentrations on a weight percent basis and thereforetheir isolation in pure form would require the harvesting and processingof literally tons of sponges. Many of these bioactive compounds mayderive their efficacy through naturally synergistic and complementarymechanisms that would be lost if purified and studied in isolation.Therefore, the present inventor has invented the technology ofdevelopment Porifera species compositions, their formulation andapplications that eliminates the need to purify and characterizeindividual bioactive compounds, maintains the integrity of theirpotentially synergistic properties and resolves the problems of supplyand environmental impact.

[0059] Fresh water sponges including, but not limited to, Spongillalacustris L., Spongilla. fragilis Leidy, and Ephydatia fluviatilis, arenot presently used to provide pharmaceutical compositions that haveundergone rigorous safety and efficacy testing. The present inventor hasdiscovered that Poriferans can be natural sources of complex biologicalsthat provide new compositions useful for treating, palliating andpreventing a variety of diseases, including, but not limited to, acnevulgaris, rosacea, seborrheic dermatitis, eczema (atopic dermatitis),psoriasis, photo-aging and actinic keratosis. The synergeticpoly-pharmacy of these complex biologicals has advantages over syntheticsingle-ingredient drugs by providing greater therapeutic benefit andless overall toxicity. Specifically, and not intended as a limitation,but merely as an exemplary embodiment of the invention, the presentinventor has developed therapeutic compositions derived form the freshwater sponge species Spongilla lacustris L.

[0060] In one embodiment of the present invention an anti-acne vulgaristherapeutic is provided that effectively treats, palliates, and in somecases prevents the most important pathological factors in acnedevelopment. These pathological factors include excessive sebumproduction, excess production of keratinocytes, outlet obstruction ofthe sebaceous follicle, P. acnes proliferation and inflammation.Furthermore, the anti-acne preparations of the present invention areconducive to therapeutic regimes and are non-toxic when used asdirected. The topical anti-acne preparations of the present inventioncan be used alone, or in combination with other topical or systemictherapeutics.

[0061] As discussed above, acne vulgaris is a common, multifactorialinflammatory disease of the pilosebaceous duct. Propionibacterium acnesproliferated in sebum, produces chemotactic factors followed byphagocytosis. This process results in the production of reactive oxygenspecies, which contribute to the inflammatory reaction in papulopustulartype acne. The overuse of antibiotics has resulted in the emergence ofantibiotic resistant strains of P. acnes thus complicating its treatmentand prevention. Approximately sixty percent of P. acnes are resistant toone or more of the antibiotics typically used to treat acne. Benzylperoxide, as an alternative treatment, kills P. acnes but promotespremature aging of the skin. Furthermore, benzyl peroxide reducesalready decreased skin levels of superoxide dismutase, catalase andother skin antioxidants that are important in preventing and healingacne. Consequently, bacterial resistance to currently availableanti-acne antibiotics, the deleterious effects of topically appliedcompounds such as benzyl peroxide and with the increased concern overthe serious side effects of oral drugs such as the retinoids, hascreated a great need for new, safe and effective treatments for acnevulgaris in addition to other skin diseases.

[0062] The mechanisms of action associated with the novel anti-acnetherapeutics of the present invention are multi-faceted. Like mostcomplex biological therapeutics such as low molecular weight heparinpreparations (e.g., enoxaparin, sodium), the exact mechanism of actionof the present compositions are not fully known. However, the presentinventor believes, without being bound to these theories, that theactive ingredients of the anti-acne preparations disclosed herein actsynergistically via one or more of following mechanisms. The presentinvention stimulates a localized histamine reaction that dilates bloodvessels thus increasing blood flow to the treatment area. This resultsin increased amounts of oxygen, nutrients, and antibodies reaching theskin cells. Due to the stimulation of blood circulation and lymphaticdrainage, the removal of excess fluid, bacteria, and debris isincreased. Moreover, the topical therapeutics of the present inventiondissolve excess sebum, reduces sebum production, and makes the excretedsebum less sticky. This prevents occlusion of the pores and consequentformation of comedones. Furthermore, refined organic residue, such as,but not limited to skeletal spicules mechanically separate epidermissurface layers reduces the keratinocytes cohesion thereby increasingstratum corneum sloughing and sebum plug and loose keratinocyte removal,which opens pores and prevents future occlusion and consequent formationof comedones. Naturally occurring antibiotic compounds kill bacteriacausing acne. Natural steroids reduce inflammation. Also it may act as avasodilator and improve local microcirculation. Continuous use thetopical therapeutics of the present invention may reduce skin fatty acidconcentrations and normalize keratin turnover in the sebaceousfollicles. Furthermore, significant clinical evidence supports theconclusion that the therapeutic preparations of the present inventionalso produce direct and indirect anti-inflammatory effect.

[0063] Multiple acne infections over time change the chemical balance ofthe skin and ultimately change the balance of the body's chemistry. Forexample, people with moderate to severe acne have significantly lesszinc in their body than people their ages that do not have acne.Furthermore, chronic acne sufferers have skin that is uniquely deficientin linoleic acid and protective antioxidants.

[0064] The present invention corrects the above imbalances allowing theskin's immune processes to effectively control bacteria and preventinfections. Accordingly, in one embodiment of the present inventioncompositions are prepared having high bioactivity and contain highconcentrations of zinc, linoleic acid, antioxidants, calcium and otherbiochemicals that act to block the conditions that lead to acne andfacilitate the healing.

[0065] When used as a peeling agent, the present invention rejuvenatesthe skin, stimulates new cell growth, elastin and collagen productionand improves skin tone and texture. The enzymes contained in thecompositions dissolve and digest old, debilitated or dead cells from theskin's outer layer without harming the younger, living cells and resultin softer, smoother skin. Overall, the compositions help to dissolvestagnant spots, infiltrates, remove superficial scars comedones,regulate skin pH and sebum production and prevent further acne eruptionand scar formation.

[0066] The present inventor has demonstrated that the compositionsdisclosed herein are effective in treating mild, moderate, and severeacne, rosacea, seborrheic dermatitis, eczema (atopic dermatitis),photo-aging and actinic keratosis. Furthermore, the compositions of thepresent invention can be used safely with traditional therapies for acneand other dermatological diseases including but not limited totraditional antimicrobial scrubs, astringents, salicylic acidpreparations and systemic therapeutics including but not limited toantibiotics and anti-inflammatory prescription drugs.

[0067] Over-the-counter preparations and prescription pharmaceuticalpreparations of the present invention are both considered within thescope of the present invention. Moreover, the compositions of thepresent invention are presently undergoing clinical trials and areintended for use in a professional environment administered and usedunder the direction of a qualified physician. As such the compositionsof the present invention may also include instructions for use andproduct labeling approved by the United States Food and DrugAdministration (USFDA) and other healthcare regulatory agenciesworld-wide. In one embodiment of the present invention product labelingand instructions for use that comply with all applicable sections of 21U.S.C. Chapter 9, Subchapter V, part A section 352 and section 21 CFRpart 201 (hereinafter referred to as FDA approved product labelingand/or package insert) are provided.

[0068] Compositions made in accordance with the teachings of the presentinvention have been analyzed extensively. The desiccated and granulatedraw material of the present invention is an odorless, grayish-rednon-hygroscopic powder. The powder is partially soluble in water andforms a greenish-red colored solution when mixed in a ratio of 1 part to3; approximately 50 to 60% percent remains insoluble and comprises theorganic fraction providing compositions of the present invention withmechanical-abrasive properties. The pH of the soluble fraction isbetween approximately 7.0 to 7.5 with a mean pH of 7.35; the specificgravity is between approximately 1.04 to 1.07 with a mean specificgravity of 1.058. Peak absorption is observed at between 210 nm to 250nm when measured between 200 and 900 nm using methods known to thoseskilled in the art of physical chemistry.

[0069] Table 1 includes a non-limiting representative analysis of theorganic and inorganic constituents. TABLE 1* Inorganic IC mg/g ofOrganic OC g/110 g of Units Component dried raw Component dried rawEnzyme Activity per (IC) material (OC) material (EA) 100 g Sodium160-170 Protein 1.90-2.00 Alkaline 80-90 Phosphatase Potassium 120-130Neutral fats 1.10-1.20 Asparagine 20-25 Transferase Ammonia 30-40Glucose 0.3-0.4 Alanine  9-10 Transaminase Calcium 160-170 Steroids0.0002 Gamma-glutamyl 7-8 Transpeptidase Magnesium 20-40 Hydroxy- TraceCatalase 50-55 purines Iron 320-330 Total Nitrogen 0.012-0.014 Malanicdialdehyde 0.15-0.2  Copper 190-200 Superoxide 6030-6040 dismutase Zinc11-13 Ceruloplasmin 450-500 Chlorine 130-140 Sulfate 115-120 Phosphate420-430 Nitrate 25-30 Bicarbonate 540-550 Carbonate 120-125 Silicates13-15

[0070] It should be understood by those skilled in the art that theelemental and organic analysis performed on representative samples isnot intended to be a comprehensive or even partial listing of the activeingredients found in the compositions of the present invention. Aspreviously discussed, there may be myriad bioactive molecules present inthe Porifera products of the present invention that have not beenpreviously identified. The analytical data in Table 1 provides personsskilled in the art non-limiting data that may be useful incharacterizing compositions made in accordance with the teachings of thepresent invention. However, in addition to other possible synergetic andcomplementary bioactive compounds contained in the present invention theingredients identified in Table 1 may also provide certain beneficialeffects. Without being bound to this theory, the present inventorproposes a possible role for many of the quantified ingredients in Table1.

[0071] The Medical Research Council in Dunn Clinical Nutrition Centre,Cambridge, United Kingdom conducted the study showing dissimilatorynitrate reduction by P. acnes isolated from human faces. Lowconcentrations of nitrite (ca. 0.2 mM) inhibited growth of P. acnes inculture. The nitrite was slowly reduced to nitrous oxide enabling growthto occur, suggesting that denitrification functions as a detoxificationmechanism.

[0072] Copper is involved in the production of collagen, the proteinresponsible for the structural integrity of bone, cartilage, skin, andtendon. It is also involved in the production of elastin, the proteinthat is mainly responsible for the elastic properties of blood vesselsand skin. Studies have proven that copper is also essential to tissuebuilding processes. As we age, our skin thins, and lines and wrinklesdevelop as our bodies become slower to produce collagen, elastin, andglycosaminoglycan (GAG). GAG functions as cement that bonds tissuecomponents together. Age spots appear and skin becomes dull and lifelessas cell renewal slows and the skin retains less moisture. Scientificstudies have demonstrated that copper plays a vital role in skin health,by helping restore the skin's ability to repair itself. Copper is apowerful collagen and elastin promoter and plays an antioxidative rolein the body. It is important in the production of GAG. Copper-dependentenzymes increase the benefits of natural tissue building processes.

[0073] Zinc, through a group of enzymes called metalloproteinases,breaks down dysfunctional tissues of acne, thereby enabling theinfection site to rebuild. Zinc directs the body's T-cells to bacteriaand infection by way of a signaling chemical called adenosine deaminase.Zinc is a key element in the production of new skin cells, new collagenand elastin, new blood vessels and other components of the skin.Moderate to severe acne literally consumes the body's supply of zinc,causing the patient to become systemically zinc deficient. When the skinis zinc deficient, the clean up and repair of infections can be slow andpossibly incomplete, allowing the potential of scarring. Zinc isespecially critical with cystic acne because cystic infections do notdischarge waste materials.

[0074] Zinc in sufficient amounts and right form acts to prevent acne aswell. Testosterone in the skin converts to dihydrotestosterone, whichstimulates the production of sebum and contributes to acne. Zinc via5-alpha-reductase inhibition blocks this conversion and thereby reducessebum production. Zinc is required in the production of the skin's superantioxidants that reduce the damage of free radicals, reducinginflammation and keeping the healing process moving forward.

[0075] Glucocorticoids are widely used for the treatment of variousdiseases, despite known side effects such as skin atrophy. Many studieshave shown that the status of collagen fibers in the skin is affected byglucocorticoid treatment. The results of a study in Japan showed thatskin treatment with glucocorticoids strongly interferes with both thesynthesis and degradation of type I collagen and, more drastically, typeIII collagen, the molecule that is known to play a major role in theinitiation of wound healing. The study provided a molecular basis forthe deterioration of skin function, impaired wound healing, and skinatrophy caused by glucocorticoid treatment. Contrary to experience withsynthetic steroids, naturally occurring steroids contained in thepresent invention provide excellent anti-inflammatory effects withoutadverse properties described above.

[0076] Enzymes are specific biological catalysts in the skin. Failure inthe production or activity impairment of a single enzyme leads tometabolic disorders and worsen the acne condition. Since activity ofmany enzymes is significantly depressed in skin with metabolic diseases,photo-aging and cancer, their presence in therapeutics is the mostdesirable for the treatment of the above mentioned diseases.

[0077] Alkaline Phosphatase (MP) is a single enzyme of the‘bone-liver-kidney’ type, which is present both in a soluble and inmembrane-bound form in the skin. It occurs almost exclusively in thedermis, not more than 1% of the total alkaline phosphatase of human skinbeing present in the epidermis.

[0078] In a study that was carried out on leukocyte enzyme activity fromprints of skin cut wounds cyto-chemical analysis revealed a rapidincrease in enzyme activity in the fourth hour after the wound occurred,which can be explained by the alteration in leukocyte metabolism inducedby the damaging agent. Thus suggesting a critical role for MP in woundhealing.

[0079] Asparaginase is enzyme that has proved to be particularlypromising for the treatment of cancer. Its action depends upon the factthat tumor cells are deficient in aspartate-ammonia ligase activity,which restricts their ability to synthesize the normally non-essentialamino acid L-asparagine. Therefore, they are forced to extract it frombody fluids. The action of the asparaginase does not affect thefunctioning of normal cells which are able to synthesize enough fortheir own requirements, but reduce the free exogenous concentration andso induces a state of fatal starvation in the susceptible tumor cells. Asixty percent incidence of complete remission has been reported in astudy of almost 6,000 cases of acute lymphocytic leukemia.

[0080] Gamma-glutamyl transpeptidase (GGT) is another enzyme critical inantioxidant and anticancer defense. GGT activity was found in both theepidermis and dermis, the former being more active. GGT is one of themost studied chemicals in cancer chemoprevention, a desirable andimportant facet of biomedical research.

[0081] Superoxide Dismutase (SOD) is the best known and perhaps mostimportant of the antioxidant enzymes. It converts the very harmful freeradicals super oxide to the less active peroxide, which is then furtherconverted by other antioxidant enzymes Catalase (CAT) into water. Thenatural synergetic interaction between these two antioxidant enzymesconstitutes the most effective system of free radical control in ourbodies. Their combined activity represents a major anti-aging factor.Deficiency in SOD/CAT is the most notorious factor in most inflammatoryprocesses.

[0082] Research suggests that SOD may be the most important enzymeinvolved in free radicals scavenging and marinating cell membraneintegrity. Compositions containing SOD/CAT have demonstrated utility aspre- and post operative supplements. When administered to surgicalpatients significant improvement in recovery rates and reducedconvalescent periods have been observed. Moreover, when used as atherapeutic SOD can exert strong regenerative effects on tissues thathave become hardened or fibroid because of age, disease, or injury.

[0083] In a study conducted by the Department of Dermatology, SuleymanDemirel University Faculty of Medicine, Isparta in Turkey, researchersinvestigated the role of reactive oxygen species in inflammation of acneby determining the activity of antioxidant defense enzymes inleukocytes. The results showed that activity of SOD was significantlydecreased in the acne group. Researchers suggested drugs withantioxidative effects are valuable in treatment of acne patient's, sincetheir antioxidative defense enzymes are severely impaired.

[0084] Ceruloplasmin (CP) is a copper-containing protein that is animportant extra-cellular antioxidant and free radical scavenger. Theliver is the primary organ that expresses CP; however, recent studieshave identified the lung as another major site of CP synthesis.Ceruloplasmin plays critical role in host defense against oxidativedamage and infection.

[0085] In an exemplary embodiment of the present invention the Poriferais used to prepare topical therapeutics is Spongilla lacustris. Asdiscussed briefly above, crude preparations of fresh water spongecolonies of mixed genus, including but not limited to Spongillalacustris L., Spongilla. fragilis Leidy, and Ephydatia fluviatilis, havebeen used by native people to prepare folk remedies (e.g. Bardiaga) forcenturies. However, these crude preparations generally compriseinconsistent mixture of various sponge genus, myriad contaminatesincluding other marine life forms, soil sediment and other debrisassociated with the Sponges' natural habitat. It is produced withoutbatch-to-batch consistency, necessary for pharmaceuticals. Moreover,sponge colonies were collected randomly without regard to environmentalconditions such as, but not limited to, the presence or absence ofpredators, water temperature and water pressure, oxygen availability,salinity, season and life cycle. Consequently, these compositions, likemany other crude natural products were seldom efficacious and oftendangerous to use. Unlike crude folk remedies the therapeuticcompositions of the present invention comprise substantially pureSpongilla powder. As used herein, “substantially pure” refers to anatural product, specifically a Porifera sp. that has been separatedfrom environmental debris including rocks, sticks, other marine lifeetc., washed, dried, ground, sieved and sized.

[0086] The present inventor has determined through analysis and clinicalresearch that harvesting conditions and formulation protocols areimportant in providing a reproducibly effective topical therapeutic.Fresh water sponges are easily identified by competently trained marinebiologists possessing no more than ordinary skill. For example, when afresh-water aquatic environment is observed Spongilla appears as dullcreamy brown to medium brown amorphous bodies. Often times larger spongecolonies will appear greenish due to algae trapped within the sponges'bodies. Furthermore, evidence of sponge viability and bioactive compoundexcretion can be observed empirically and include such factors as thelack of algal overgrowth and low predation rate.

[0087]Spongilla lacustris is generally preferred for making thecompositions of the present invention because this sponge genus ishighly tolerate of natural environmental variation and grows extremelywell in a wide range of habitats. In order to avoid collectingenvironmentally induced variants having less than ideal potency thepresent inventor has determined that S. lacustris is preferablycollected at summer's end on warm sunny days. If sudden environmentalchanges occur which adversely affect sponge viability harvesting shouldbe terminated.

[0088] Aquatic environments favorable to S. lacustris production includean identifiable substratum having submerged rocks, sticks and branches.Generally, lakes are better natural habitats than rivers and streams forthe development of large sponge colonies due to the absence of strongcurrents. In still waters such as lakes freshwater sponges form coloniesranging from 2.4 to 40 cm across in deer-horn-shape, finger- andbush-like forms. Water clarity is also an important environmental factorin supporting large, developed Spongilla lacustris colonies. Waterclouded by dirt, mud and dissolved solids depress sponge growth thusreducing colony size and sponge quality. Consequently, muddy, cloudy andturbulent waters, as well as lakes having contaminated source watersshould be avoided when selecting harvest locations. In one embodiment ofthe present invention S. lacustris is harvested from fresh water lakesin the Russian Federation northwest of the Caspian Sea, specificallyAstrahan region as depicted in FIG. 1 at 101.

[0089] Once an appropriate aquatic environment and sponge habitat isidentified sponge collection can begin using methods commonly known tothose skilled in the art of marine biology. For example, sponges can becollected manually using basic under water diving techniques, or indeeper waters larger colonies are harvested using the Agassiz trawl(AGT) or epibenthic sledge (EBS). However, sponges smaller than 0.5 cmin diameter are unlikely to be collected by AGT. Under certainenvironmental conditions S. lacustris colonies occur in a thincrust-like carpet several meters across and must be collected manually,with fork-like tools, and nets.

[0090] Freshly collected sponges removed from their aquatic habitat aremucoid amorphous masses and emit a characteristic odor that mostobservers describe as unpleasant. Before the collected sponge mass isdried it must be clean of gross contamination including portions of thesubstrata, shells, stems, plants, small fresh water animals, rocks andother impurities. Next the sponge mass is washed to remove dirt, sand,silt and soluble impurities. The wash water is changed repeatedly untilit is clear and the sponges appear free from contamination. Afterremoving gross debris and cleaning, the sponge mass is weighed anddried. Drying is preferable done in the open air on a warm clear day.However, commercial scale dryers used to dehydrate foods andpharmaceuticals can be used as appropriate. Generally, sponge harvestingis done in remote rural regions due to the difficulties associated withdeveloping and sustaining artificial “sponge farm” habitats.Consequently, large commercial drying facilities are seldom available.As an alternative, collected sponge colonies can be sent to therepository, a low-temperature storage facility for their quarantine,delayed processing and further investigation.

[0091] When dried under ambient, open-air conditions temperature, dewpoint, relative humidity and forecasted precipitation must be closelymonitored. If the ambient air temperature is too low or if precipitationis forecasted the sponge mass should be dried inside where temperatureand humidity can be controlled. It is not essential that a precisetemperature or humidity range be maintained, however, the sponge massshould be maintained within a temperature and humidity range suitablefor an uninterrupted evaporative process to proceed. For example,temperatures should be above 60° F. and relative humidity should bebelow 90%. However, it is recommended that the sponge mass should beprotected from exposure to atmospheric precipitation and excessivetemperatures after collection. The sponge mass is dried until residualmoisture content is less than 10%, preferably less than 5%. If the rawmaterial is to be stored for protracted periods before furtherprocessing, residual moisture can be as low a 0.1% or less. Residualmoisture measurements can be performed using methods commonly known inthe arts of food sciences, analytical chemistry or the pharmaceuticalsciences. For example, 10 grams of dried material is placed on a taredweighing boat and then weighed. The weighed material is then exposed toa heat source such as a drying oven or heat lamp operated at atemperature sufficient to evaporate any remaining free or loosely boundwater (non-chemically bound). The sample is then cooled in a desiccatedchamber and re-weighed. Residual moisture is calculated as the percentdifference between the sample weight before drying and the weight aftercooling.

[0092] Once dried, the sponge is packaged in sealed containers,protected from light and maintained in quarantine at 55° to 75° F.Routine quality control processes are conduced on the dried spongematerial consistent with Good Manufacturing Practice Requirements (GMP)and International Standards Organization (ISO) regiments applicable tofood, drugs and cosmetics before being released from quarantine andprocessed further. Testing includes microbiological culturing forpathogens, coliform organisms and bioburden. Chemical analysis is alsoperformed to verify the product's identity, potency and purity. Allprocessing after the initial drying phase should be conducted inenvironmentally controlled facilities that comply with GMP and ISOguidelines. Manufacturing personnel must be trained in GMP and ISOprocedures and all manufacturing process closely monitored and recorded.

[0093] After release from quarantine the raw, dried material sponge isfurther refined and processed to a standard particle size using sieves.The dried sponge is extremely fragile and requires only slight, gentlegrinding to form a consistently fine particulate. The dried spongescollected and processed in accordance with the teachings of the presentinvention should not be processed using aggressive grinding techniques,rather the dried sponge is processed gently to avoid crushing debristhat may be present in the sample. For example, shells from aquaticmollusks may contaminate the crude sample; grinding of the crude spongepreparation should be conducted in a fashion that will not pulverize thecontaminating shells to a degree that they would not be removed in thesieving processes. Several grinding and sieving steeps are performed toreduce average particle size to no more than 0.2 mm. First a coursegrind and sieving process is used to reduce particle size to at least 2mm. This initial sieving process also permits visual inspection andremoval of remaining non-sponge debris and is followed by subsequentgrinding and sieving processes where the raw material is ultimatelyreduced to no more than 0.2 mm particles.

[0094] Next the sized material is ground and sieved again to reduceparticle size to more than 0.2 mm. After the desiccated sponge powder isground, it is further purified and separated from contaminates byprocessing the powder with sieves having progressively smaller apertures(1 mm, 0.5 mm, and 0.2 mm respectively). All processing is conductedunder GMP conditions.

[0095] After final grinding and sizing processes are completed the driedsponge material is packaged in airtight moisture-proof containers andstored in the dark at 550 to 75° F. under desiccated conditions. Nopreservatives are required due to the natural antimicrobial propertiesof the Spongilla powder. Spongilla powder collected, processed andstored in accordance with the teachings of the present invention isstable for a minimum of three years and six months (stability dataavailable as of the filing date of the instant patent). However,accelerated testing data may suggest much longer stability periods (upto 10 years).

[0096] The therapeutic compositions of the present invention comprisefrom approximately 0.1% to 100% substantially pure Spongilla powder andcan optionally compounded with pharmaceutical excipients including, butnot limited to water, saline, buffered phosphate, oils, gels, waxes,emollients, glycerin, cleansers, fragrances, colorings, antiseptics andanesthetics. Suitable waters include water for injection, irrigationwater, distilled water, deionized water, and floral water among others.Even clean tap water is acceptable for some applications. Theconcentrations of the aforementioned excipients can range from 0.001% to50% or more depending on the requirements and at the discursion of theformulation scientist, pharmacist or prescribing physician. Such rangesare well known in the art and can be determined without undueexperimentation. Other excipients that may be used in accordance withthe teachings of the present invention may include from approximately0.1% to 25% coral powder, from approximately 0.1% to 25% seaweed powder,from approximately 0.1% to 10% hydrogen peroxide and from approximately0.1 to 10% of an inorganic or organic acid such as, but not limited toboric acid, hydrochloric, ascorbic acid, salicylic acid, and others.

[0097] The therapeutic compositions of the present invention generallycomprise from 0.8 to 1.5 grams of substantially pure Spongilla powder,and at least one additional excipient selected from the group consistingof from 0.1 to 0.5 grams of green seaweed powder, from 0.1 to 0.5 gramsof white seaweed powder, from 0.1 to 0.5 grams of coral powder, from 0.1to 0.5 grams of Plantain powder, from 0.5 mL to 5 mL of 0.1% to 10%hydrogen peroxide, from 0.5 mL to 5 mL of 0.1% to 10% boric acid andfrom 0.5 to 5 mL of water, from 0.5 mL to 5 mL enzyme gel (comprisingwater, hydroxyethylcellulose, hyaluronic acid, propylene glycol,methylparaben, tetrasodium EDTA and propylparaben in proportionssuitable for topical applications as known to those skilled in the art),from 0.5 mL to 10 mL jojoba oil. Other excipients such as, but notlimited to saline, buffered phosphate, oils, waxes, emollients,glycerin, cleansers, fragrances, colorings, antiseptics and anestheticsmay be added as desired or required.

EXAMPLES

[0098] The following examples provide formulations using exact amountsin grams and milliliters of each ingredient. However, these exactweights and volumes should not be considered limitations. All of theliquids used herein are aqueous based and contain low percentages ofsolute. Therefore, the relative weight of each volume of liquidingredient will be considered equal to the weight of water (1 g/mL). Theappended claims will therefore be expressed as ratios. For example, acomposition made in accordance with the teachings of the presentlyinvention may contain 1.5 g of substantially pure Spongilla powder, 0.5mL hydrogen peroxide, 2 mL of 5% boric acid, 1 gram of green sea weedpowder and 10 mL of floral water. This composition would then be claimedas follows: 1.5 parts of substantially pure Spongilla powder, 0.5 parts3% hydrogen peroxide, 2 parts of 5% boric acid, 1 part of green sea weedpowder and 10 parts of floral water; etc.

Example 1 Basic Topical Acne Treatment

[0099] Therapeutic compositions prepared from the dried Spongilla powdercan be prepared using formulating excipients and procedures known tothose skilled in the art of topical medicament preparation. For example,in one embodiment of the present invention topical acne therapeuticcomprises of 1.0 grams of Spongilla powder (active ingredient) and 2.0milliliter of 3% hydrogen peroxide (vehicle). The ingredients arecombined and mixed together. The mixture then is heated in the microwavefor about 7 seconds. During heating hydrogen peroxide transforms intowater and oxygen, which results in fluffy mask of homogeneousconsistency. The therapeutic is then applied to the entire face inmassaging circular motions, left on for 15 to 30 minutes, and thenwashed off with water. Recommended usage is every 5 to 7 days.

Example 2 Topical Acne Treatment for Professional Use

[0100] In another embodiment of the present invention, topical acnetherapeutic comprises of 1.5 grams of Spongilla powder, 1.0 milliliterof 3% hydrogen peroxide, and 3.0 milliliters of 5% boric acid. Themixture and application of this topical anti-acne composition forprofessional use includes mixing the powder with warm liquids justbefore use. The therapeutic is then applied to the face or otheraffected area in circular motions, left on for 25 to 30 minutes, andthen washed off with water. Recommended usage is every 4 to 5 days.

Example 3 Topical Acne Composition for Home Use

[0101] In one embodiment of the present invention topical acnetherapeutic for home use comprises 0.8 grams of Spongilla powder, 0.2grams of Plantain powder and 2.5 milliliters of enzyme gel. The mixtureand application of this topical anti-acne composition for home useincludes mixing the powder with liquid just before use. The contents arethen applied to the face or other affected area with a brush, left todry for 15 minutes and then washed off with water. Recommended usage isevery day for a week or until face is cleared and then once a week formaintenance.

Example 4 Professional Skin Resurfacing Composition

[0102] Formulas suitable for professional skin resurfacing comprise of1.5 grams of Spongilla powder, 0.2 grams of green seaweed powder, 5.0milliliters of 3% hydrogen peroxide. The mixture and application of thisprofessional skin resurfacing formula includes mixing the powder withhot liquid just before use. The contents are then applied to the face orother affected area in a circular motion for approximately 5 minutes.Mixture is than left to dry for 25 to 30 minutes and then washed offwith water. Recommended usage is once a week.

Example 5 Topical Oily Skin Treatment

[0103] Formulas for treatment of oily skin may comprise 1.0 grams ofSpongilla powder and 2.0 milliliters of chamomile, menthol or calendulawater. The mixture and application of this professional skin resurfacingformula includes mixing the powder with warm liquids just before use.The contents are left on for 5 to 10 minutes and then washed off withwater. Recommended usage is every 2 days until sebum production issuppressed and then every 10 days for maintenance.

Example 6 Topical Deep Peeling Skin Treatment

[0104] Formulas for deep peeling of the skin may comprise of 1.5 gramsof Spongilla powder, 0.3 grams of green seaweed powder, and 5.0milliliters of 4% hydrogen peroxide. The mixture and application of thisprofessional deep peeling formula includes a 7 day process. On the firstday, the face or effected area is to be steamed. The powder is mixedwith hot liquid just before use. The contents are then applied to theface or other affected area in a circular motion. After 5 to 6 minutes,a mask is saturated with hydrogen peroxide in circular motions. It isleft to dry for 20 minutes and washed off with water. On day 2, the faceor effected area is washed with 2% salicylic acid. The contents are thenapplied to the face or other affected area in a circular motion. After 5to 6 minutes, a mask is saturated with hydrogen peroxide in circularmotions. It is left to dry for 20 minutes and washed off with water. Onthe third and fourth days boric ointment is applied to effected areas.On the fifth and sixth days, a moisturizer and soothing mask is applied.On the seventh and last day of treatment, the effected area isexfoliated with a scrub. Recommended usage is once a month.

Example 7 Treatment of Hyperpigmentation Disorders

[0105] Formulas for hyperpigmented spots removal (including but notlimited to melasma, age spots, sun-damage, etc.) of the skin maycomprise of 1.0 grams of Spongilla powder, 0.2 grams of white seaweedpowder and 3.0 milliliters of enzyme gel. The contents are then mixedtogether and applied to the face or other affected area in massagingcircular motions for approximately 10 minutes, left to dry for 25 to 30minutes and then washed off with water. Recommended usage is twice aweek.

Example 8 Treatment for Photo-Damaged and Aging Skin

[0106] Formulas for photo-damaged skin may comprise of 2.0 grams ofSpongilla powder and 5.0 milliliters of jojoba oil. The mixture andapplication of this formula for photo-damaged and aging skin includesmixing the powder with hot oil just before use. The contents are thenmassaging into the face or other affected in circular motions for 30 to45 minutes, left to stay for 25 to 30 minutes and then washed off withwater. Recommended usage is once a week.

Example 9 Treatment for Seborrhoeic Dermatitis of the Scalp

[0107] Formulas for seborrhoeic dermatitis of the scalp comprise 5.0grams of Spongilla powder, 5.0 milliliters of 3% of hydrogen peroxideand 5.0 milliliters of 2% of boric acid. The mixture and application ofthis professional skin resurfacing formula includes mixing the powderwith hot liquids just before use. The contents are then applied to theaffected area in a circular massaging motion. Mixture is than left for30 minutes and then washed off with water. Recommended usage 5 to 6 daysfor 8-10 weeks and then, once a month for maintenance.

[0108] The preceding exemplary embodiments are not intended aslimitations and the Porifera compositions of the present invention maybe formulated in myriad ways and still be considered within the scope ofthe present invention. The present inventor believes that desiccatedSpongilla powdered comprises numerous biologically active compoundsbeneficial to promoting skin health, promoting healing and reducingscarring. These beneficial compounds include, but may not be limited toantibacterial, anti-inflammatory, antiviral and other organic bioactiveagents in addition to inorganic compounds such as iodine, bromine,phosphorus and sulfur.

[0109] The exact mechanism of action of the Spongilla compositions ofthe present invention remains unknown. Moreover, the present inventorbelieves that the natural combination of ingredients contribute to asynergistic effect that may be destroyed or significantly reduced byextraction and purification of the aforementioned active ingredients.However, the present inventor has demonstrated safety and efficacy ofthe present invention as detailed in the following, non-limitingdisclosure.

Safety Testing

[0110] I. In Vivo Rabbit Tests

[0111] The test article, Desiccated Animal Sponge-Thistle, Batch: SanPin 2.3.2.560-96, was evaluated for primary skin irritation inaccordance with the guidelines of the International Organization forStandardization 10933: Biological Evaluation of Medical Devices, Part10: Tests for Irritation and Sensitization. Two 0.2 g portions of thetest article moistened with 5 drops of 0.9% sodium chloride and vehiclecontrol article were topically applied to the skin of each of threerabbits and left in place for 24 hours. The sites were graded forerythema and edema at 1, 24, 48 and 72 hours after removal of the singlesample application. Under the conditions of this study, no erythema andno edema were observed on the skin of the rabbits. The PrimaryIrritation Index for the test article was calculated to be 0.0. Theresponse of the test article was categorized as negligible.

[0112] The test article identified below was evaluated for primary skinirritation in accordance with the guidelines of the InternationalOrganization for Standardization 10933: Biological Evaluation of MedicalDevices, Part 10: Tests for Irritation and Sensitization. The purpose ofthis study was to determine the potential for a single topicalapplication of the test article to irritate skin of the rabbit. The testarticle was received on Aug. 30, 2002. Patches were applied on Sep. 5,2002, and the observations wee concluded on Sep. 9, 2002 was conductedin accordance with the provisions of the FDA Good Laboratory Practice(GLP) Regulations, 21 CFR 58. Materials Test Article: Desiccated AnimalSponge-Thistle Identification No.: Batch: San Pin 2.3.2.506-96 StabilityTesting: Complete and on file with the sponsor (per sponsor) ExpirationDate: April, 2004 Vehicle: 0.9% Sodium Chloride, sterile saline StorageConditions: Dry, dark conditions: Control Article: Four-ply gauzesupplied by the test facility, was cut into 25 mm × 25 mm sections andmoistened with 5 drops of 3% hydrogen peroxide per section. Preparation:0.2 gram portion of the test article (weighted by sponsor prior tosubmission), Desiccated Animal Sponge-Thistle, was moistened with 5drops of 0.9% sodium chloride. The test article and saline were mixed toform a paste consistency. The test mixture was applied to the animals'skin and allowed to air dry for 20 minutes, then wrapped with 4-plygauze. Test System: Male Rabbits (Oryctolagus Cuniculus) New Zealand

Experimental Procedure

[0113] On the day prior to treatment, the fur on each rabbit's back wasclipped with an electric clipper. On the day of treatment, four sites,two on each side of the back and positioned cranially and caudally, weredesignated on each rabbit. The sites were free of blemishes that couldinterfere with the interpretation of results.

[0114] A 0.2 g portion of the test article was moistened with 5 drops ofsaline, and applied to each caudal site (two sites per rabbit)approximately 25 mm×25 mm square. The test article mixture was allowedto air dry for 20 minutes prior to wrapping. The control vehicle wassimilarly applied to the caudal sites. The trunk of each animal waswrapped with an elastic binder to maintain the test patches in position.Animals were returned to their cages after treatment.

[0115] After the 24 hour exposure, the binders, tape, and patches wereremoved. The sites were gently wiped with a gauze sponge dampened withdeionized water in an attempt to remove any remaining residue. Dermalobservations for erythema and edema were recorded at 1, 24, 48 and 72hours after patch removal.

[0116] The Primary Irritation Index of the test was calculated followingtest completion for each animal. The erythema and edema scores obtainedat the 24, 48 and 72 hour intervals were added together and divided bythe total number of observations. This calculation was conductedseparately for the test and control article for each animal. The scorefor the control was subtracted from the score for the test article toobtain the Primary Irritation Score. The Primary Irritation Score (seeTable 2) for each rabbit was added together and divided by the number ofrabbits to obtain the Primary Irritation Index (see Table 3).

Results

[0117] No irritation was observed on the skin of the rabbits assummarized in Table 1. The Maximum Irritation Response was notapplicable. The Primary Irritation Index of the test article wascalculated to be 0.0. The irritation calculations are shown below: TABLE1 Combined Primary Test Individual Primary Irritation Score ControlPrimary Irritation Index Rabbit Aver- Score Irritation Score (CPIS ÷Response Number age Average Score (CPIS) 3) Category 65977 0.0 0.0 0.00.0 0.0 Negligible 65976 0.0 0.0 0.0 65975 0.0 0.0 0.0

[0118] TABLE 2 Classification System for Skin Reaction NUMERICALReaction GRADING Erythema and Eschar Formation No erythema 0 Very slighterythema (barely perceptible) 1 Well-defined erythema 2 Moderateerythema 3 Severe erythema (beet redness) to 4 eschar formationpreventing grading of erythema Edema Formation No edema 0 Very slightedema (barely perceptible) 1 Well-defined edema (edges of area 2well-defined by definite raising) Moderate edema (raised approximately 1mm) 3 Severe edema (raised more than 1 mm 4 and extending beyondexposure area) Total possible score for irritation 8

[0119] TABLE 3 Irritation Response Categories in the Rabbit RESPONSECATEGORY MEAN SCORE Negligible 0.0 to 0.4 Slight 0.5 to 1.9 Moderate 2.0to 4.9 Severe 5.0 to 8.0

Safety Testing: Conclusion

[0120] Under the conditions of this study, no erythema and no edema wereobserved on the skin of the rabbits. The Primary Irritation Index forthe test article was calculated to be 0.0. The response of the testarticle was categorized as negligible.

[0121] II. In Vivo Guinea Pig Tests

[0122] The test article described below was evaluated for the potentialto cause delayed dermal contact sensitization following repeatedocclusive patching in the guinea pig. The study was conducted based onthe requirements of the International Organization for Standardization10993: Biological Evaluation of Medical Devices, Part 10: Tests forIrritation and Sensitization. The test article was received on Aug. 30,2002. The first patch was applied on Sep. 17, 2002, and the observationswere concluded on Oct. 22, 2002. The susceptibility of the Hartleyguinea pig strain to a known sensitizing agent,1-chloro-2,4-dinitrobenzene (DNCB), has been substantiated.

[0123] The study was conducted in accordance with the provisions of theFDA Good Laboratory Practice (GLP) Regulations, 21 CFR 58 Materials TestArticle: Desiccated Animal Sponge-Thistle Identification No: Batch: SanPin 2.3.2.560-96 Stability Testing: Complete and on file with thesponsor (per sponsor) Expiration Date: April, 2004 Storage Conditions:Dry, dark conditions Control Article: Approximate 25 mm × 25 mm sectionsof 4-ply gauze were used as the vehicle. Preparation: A 0.2 gram portionof the test article (weighed by sponsor prior to submission), DesiccatedAnimal Sponge-Thistle, was moistened with 5 drops of 3% hydrogenperoxide. The test article and hydrogen peroxide were mixed to form apaste consistency. The 0.2 grain portion of test article mixture wasused for approximately 5 patches applied to the animals'skin. The testmixture was allowed to air dry for 20 minutes, then wrapped with 4-plygauze. Species: Female Guinea pig (Cavia porcellus) Crl: (HA) CharlesRiver Laboratories Body Weight Range: 311 grams to 366 grams the dayprior to first treatment

[0124] The Hartley albino guinea pig has been used historically forsensitization studies. Repeated patching of the test material tofur-clipped intact skin will be employed. Topical applications arerelated to the human exposure route and will permit the evaluation ofdermal contact and/or absorption of potential sensitizers duringinduction and challenge phases. Reactions directly under the topicalapplication site can be observed. The susceptibility of the Hartleystrain to a known sensitizing agent, 1-chloro-2,4-dinitrobenzene (DNCB),has been substantiated.

Experimental Procedure

[0125] On the day prior to the first induction treatment, each animalwas weighed and identified. The hair was removed with an electricclipper from the left flank of 10 guinea pigs designated as test animalsand 5 guinea pigs designated as control animals. Each animal wasobserved daily for general health.

[0126] The following day, an aliquot of the test mixture was applied toan approximate 25 mm×25 mm area of the appropriate animals. The testmixture was allowed to dry for 20 minutes before wrapping. The patch wasthen secured with hypoallergenic tape to the intact skin. To maintainthe occluded patch in position, the trunk of each guinea pig was wrappedwith an elastic band.

[0127] At 6 to 8 hours, the wraps and patches were removed. The siteswere wiped with dry gauze after patch removal to remove any materialresidue from the skin. Observations for dermal responses were recorded24 hours following the completion of each test article exposure. Priorto scoring, the sites were wiped with 35% isopropyl alcohol saturatedgauze.

[0128] The application procedure was repeated three times each week(e.g. Monday-Wednesday-Friday) for 3 weeks until nine applications weremade to the left flank of the animals. The hair was clipped the dayprior to each application to provide a clear site.

[0129] At 13 days after the final induction patch, the hair of eachguinea pig was removed with an electric clipper from the right flankarea. On the following day, an approximate 25 mm×25 mm section of boththe control and test article was applied to the intact skin on thedorsal and ventral regions of the right flank of each test and controlguinea pig. The trunk of each guinea pig was wrapped with an elasticband to hold the occluded patch in place.

[0130] All wraps and patches were removed 6 to 8 hours later. The siteswere wiped with dry gauze after patch removal. At 24 hours after patchremoval, the challenged sites and surrounding area were shaved.Observations for dermal reactions were conducted at 2-4 hours followingthe shave and at 48 and 72 hours after challenge patch removal. Siteswere wiped with 35% isopropyl alcohol saturated gauze before scoring ateach interval. Evaluations for both the induction and challenge phaseswere based on dermal reactions which were scored as outlined below inTable 4. TABLE 4 Dermal Reactions ERYTHEMA (ER) EDEMA (ED) NumericalNumerical Reaction Grading Reaction Grading No erythema 0 No edema 0Slight erythema 1 Slight edema 1 Well-defined erythema 2 Well-defined 2edema Moderate erythema 3 Moderate edema 3 Severe erythema to slight 4Severe edema 4 eschar formation

[0131] Following the challenge patch, any test animal exhibiting adermal reaction greater than that observed in the challenge controlconditions was considered as showing delayed contact sensitization tothe test article. Pattern and duration of reactions was also consideredin the final evaluation.

Results

[0132] Clinical Observations: Individual body weights are presented inAppendix 1. All animals appeared clinically normal throughout the study.

[0133] Dermal Observations: Individual results of dermal scoring for theinduction and challenge phases appear in Tables 5 and 6. No evidence ofsensitization was observed. All procedures were conducted in conformancewith good laboratory practice and ISO 17025. TABLE 5 Individual BodyWeights and Clinical Observations Animal Number/ Individual ObservationGroup Pretreatment Body Weight (g) Clinical Observations  1 Test 327Appeared normal  2 Test 354 Appeared normal  3 Test 325 Appeared normal 4 Test 311 Appeared normal  5 Test 344 Appeared normal  6 Test 333Appeared normal  7 Test 324 Appeared normal  8 Test 333 Appeared normal 9 Test 343 Appeared normal 10 Test 334 Appeared normal 11 Control 366Appeared normal 12 Control 347 Appeared normal 13 Control 325 Appearednormal 14 Control 355 Appeared normal 15 Control 329 Appeared normal

[0134] TABLE 6 Guinea Pig Sensitization Dermal Reactions - InductionAnimal Induction Patch Number Number/ 1 2 3 4 5 6 7 8 9 Group ER ED ERED ER ED ER ED ER ED ER ED ER ED ER ED ER ED  Test 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0  2 Test 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0  3 Test 0 01 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0  4 Test 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00  5 Test 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0  6 Test 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 0 0  7 Test 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0  8 Test 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0  9 Test 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 10 Test 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 11 control 0 0 0 0 0 00 0 0 0 0 0 0 0 0 0 0 0 12 Control 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 013 Control 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 14 Control 0 0 0 0 0 0 00 0 0 0 0 0 0 0 0 0 0 15 Control 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

[0135] TABLE 7 Dermal Reactions - Challenge Hours After Patch RemovalAnimal 24 48 72 Number/ Test Site Control Site Test Site Control SiteTest Site Control Site Group ER ED ER ED ER ED ER ED ER ED ER ED  1 Test0 0 0 0 0 0 0 0 0 0 0 0  2 Test 0 0 0 0 0 0 0 0 0 0 0 0  3 Test 0 0 0 00 0 0 0 0 0 0 0  4 Test 0 0 0 0 0 0 0 0 0 0 0 0  5 Test 0 0 0 0 0 0 0 00 0 0 0  6 Test 0 0 0 0 0 0 0 0 0 0 0 0  7 Test 0 0 0 0 0 0 0 0 0 0 0 0 8 Test 0 0 0 0 0 0 0 0 0 0 0 0  9 Test 0 0 0 0 0 0 0 0 0 0 0 0 10 Test0 0 0 0 0 0 0 0 0 0 0 0 11 Control 0 0 0 0 0 0 0 0 0 0 0 0 12 Control 00 0 0 0 0 0 0 0 0 0 0 13 Control 0 0 0 0 0 0 0 0 0 0 0 0 14 Control 0 00 0 0 0 0 0 0 0 0 0 15 Control 0 0 0 0 0 0 0 0 0 0 0 0

Safety Testing: Conclusion

[0136] Under the conditions of this study, the Spongilla therapeuticcompositions of the present invention did not show any evidence ofdelayed dermal contact sensitization in the guinea pig. Thus, whenSpongilla preparations are prepared in accordance with the teachings ofthe present invention there are no demonstrable toxic and allergicreactions induced in the recipient.

[0137] Exemplary Method for Using the Porifera Compositions of thePresent Invention Introduction:

[0138] A pre-weighed package containing substantially pure Spongillapowered is provided. The pre-weighed amount is sufficient for oneapplication to the face. Alternatively, this application can be used totreat the chest, neck, or shoulders instead of face. The treatment maybe performed by a medical doctor, a nurse or patient, trained in theprocedure. It can be safely administered to patients of all skin types.The patient should be informed to avoid unprotected sun exposure for twoweeks prior to each treatment. Products such as glycolic acid (over-thecounter-strength), Retin-A, and Renova should be discontinued for atleast 14 days prior to treatment. A longer period of time (severalmonths) must be allowed to pass following professional strength glycolicacid, Jessner's, phenol and TCA peels; CO₂ laser resurfacing and Erbiumlaser peels. However, in medical office each case may be examinedindividually.

[0139] The treatment areas should be washed with a mild cleanser aftermake-up is removed. The person performing the procedure may wearprotective gloves (it is not a requirement).

[0140] Treatment Preparation:

[0141] Measure out two milliliters of 3% hydrogen peroxide into a small(about 30 ml-50 ml) non-metal container. Gently heat in a microwave tobring the solution to a lukewarm temperature. Using a 1300 wattmicrowave, time setting is usually 2-10 seconds depending on whether thecontainer is glass or plastic. Pour the warmed peroxide solution intothe pre-weighed container of Spongilla powder. Gently stir to obtain athin paste of fairly homogeneous consistency. Alternatively, the powdercan be mixed with the hydrogen peroxide first and then warm.

[0142] Treatment Application:

[0143] Apply one quarter of the amount to the mid-forehead by massagingin circular motions. Spread the paste gently with your fingertips insmall circular movements up to the hairline using even pressure. As thispaste begins to dry, repeat the same steps as you move down the temples,cheeks, nose and chin. Mild to moderate erythema usually develops. Asensation of sharp crystal needles under the skin is commonlyexperienced during application. It is best to avoid the periorbital areabecause the skin is thinner and more sensitive. It is extremelyimportant to massage the paste into the skin before it dries to optimizepenetration of active ingredients into the skin. This may take 5 minutesfor the face. The neck and chest should always be done last. The mostcomfortable way to rinse the face is to have the patient splash coldwater rather than to wipe their face with a wet washcloth. The skinerythema and tingling sensation of the skin gradually fades over thefollowing 12-24 hours. Recommended Treatment Times* Total Suggested TimeFace 10-30 minutes Neck  5-20 minutes Chest  5-20 minutes

[0144] Instruct the patient to use a sunscreen with SPF 30-40,preferably one with zinc to help soothe the skin, for at least 2 weeksafter each treatment. Explain that failure to do so may result inhyperpigmentation. For the best results, the patient should avoidapplying a moisturizer for at least 12 hours. Rich moisturizers shouldbe avoided during the course of treatment. Use of powder make-up or alight foundation can be resumed after the first 12 hours. All patientsmust be instructed to do the exfoliating on the 5^(th)-6^(th) day athome with scrub provided or return to the office for exfoliatingprocedure.

Efficacy Testing

[0145] In one embodiment of the present invention a patient, depicted inFIG. 2 was treated using the therapeutic compositions prepared from thedried Spongilla powder and formulated as disclosed above. Morespecifically, the topical therapeutic was formulated as a topical acnetherapeutic comprising of 1.0 grams of Spongilla powder and 2.0milliliter of 3% hydrogen peroxide mixed prior to use and heated in themicrowave for 7 seconds. The topical composition was applied to theentire face with circular motions under the supervision of a trainedphysician. The treatment was left in contact with the patient's skin for25 minutes, and then washed off with water. This treatment protocol wasrepeated every 7 days for 4 weeks. After treatment was completed thepatient appears as depicted in FIG. 3.

[0146] The therapeutic compositions of the present invention are derivedfrom Porifera species and can be used to treat myriad skin diseases anddisorders. Specifically, the present invention providesSpongilla-derived topical therapeutics effective in the treatment ofacne vulgaris, rosacea, seborrheic dermatitis, eczema (atopicdermatitis), psoriasis, photo-aging, actinic keratosis, and great numberof other bacterial, viral, and fungal diseases as well as skinpigmentation disorders. Several exemplary embodiments are provided;however, it is understood by those skilled in the art of pharmaceuticalcompounding that many other compositions are possible without departingfrom the spirit of the claimed invention.

[0147] Unless otherwise indicated, all numbers expressing quantities ofingredients, properties such as molecular weight, reaction conditions,and so forth used in the specification and claims are to be understoodas being modified in all instances by the term “approximately.”Accordingly, unless indicated to the contrary, the numerical parametersset forth in the following specification and attached claims areapproximations that may vary depending upon the desired propertiessought by the present invention. At the very least, and not as anattempt to limit the application of the doctrine of equivalents to thescope of the claims, each numerical parameter should at least beconstrued in light of the number of reported significant digits and byapplying ordinary rounding techniques. Notwithstanding that thenumerical ranges and parameters setting forth the broad scope of theinvention are approximations, the numerical values set forth in thespecific examples are reported as precisely as possible. Any numericalvalue, however, inherently contains certain errors necessarily resultingfrom the standard deviation found in their respective testingmeasurements.

[0148] The terms “a” and “an” and “the” and similar referents used inthe context of describing the invention (especially in the context ofthe following claims) are to be construed to cover both the singular andthe plural, unless otherwise indicated herein or clearly contradicted bycontext. Recitation of ranges of values herein are merely intended toserve as a shorthand method of referring individually to each separatevalue falling within the range. Unless otherwise indicated herein, eachindividual value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context. The use of any and allexamples, or exemplary language (e.g., “such as”) provided herein isintended merely to better illustrate the invention and does not pose alimitation on the scope of the invention otherwise claimed. No languagein the specification should be construed as indicating any non-claimedelement essential to the practice of the invention.

[0149] Groupings of alternative elements or embodiments of the inventiondisclosed herein are not to be construed as limitations. Each groupmember may be referred to and claimed individually or in any combinationwith other members of the group or other elements found herein. It isanticipated that one or more members of a group may be included in, ordeleted from, a group for reasons of convenience and/or patentability.When any such inclusion or deletion occurs, the specification is hereindeemed to contain the group as modified thus fulfilling the writtendescription of all Markush groups used in the appended claims.

[0150] Preferred embodiments of this invention are described herein,including the best mode known to the inventors for carrying out theinvention. Of course, variations on those preferred embodiments willbecome apparent to those of ordinary skill in the art upon reading theforegoing description. The inventor expects skilled artisans to employsuch variations as appropriate, and the inventors intend for theinvention to be practiced otherwise than specifically described herein.Accordingly, this invention includes all modifications and equivalentsof the subject matter recited in the claims appended hereto as permittedby applicable law. Moreover, any combination of the above-describedelements in all possible variations thereof is encompassed by theinvention unless otherwise indicated herein or otherwise clearlycontradicted by context.

[0151] In closing, it is to be understood that the embodiments of theinvention disclosed herein are illustrative of the principles of thepresent invention. Other modifications that may be employed are withinthe scope of the invention. Thus, by way of example, but not oflimitation, alternative configurations of the present invention may beutilized in accordance with the teachings herein. Accordingly, thepresent invention is not limited to that precisely as shown anddescribed.

I claim:
 1. A composition for treating skin diseases comprising aPorifera-derived product made in accordance with Good ManufacturingPractices (GMP).
 2. The composition according to claim 1 wherein saidPorifera is a sponge.
 3. The composition according to claim 1 whereinsaid skin disease is selected from the group consisting of acnevulgaris, rosacea, seborrheic dermatitis, atopic dermatitis, psoriasis,photo-aging and actinic keratosis.
 4. The composition according to claim2 wherein said sponge is a fresh water sponge.
 5. The compositionaccording to claim 4 wherein said fresh water sponge is selected fromthe group consisting of Spongilla lacustris L., Spongilla. fragilisLeidy, and Ephydatia fluviatilis.
 6. The composition according to claim5 wherein said fresh water sponge is Spongilla lacustris.
 7. Thecomposition according to claim 6 wherein said Spongilla lacustris isharvest from the Arstrakian region of the Russian Federation.
 8. Thecomposition according to claim 1 further comprising pharmaceuticallyacceptable excipients.
 9. The composition according to claim 1 furthercomprising United States Food and Drug Administration (USFDA) approvedpackaging, labels and directions for use.
 10. A therapeutic compositionfor treating acne comprising from 0.1% to 100% Spongilla powder.
 11. Thetherapeutic composition for treating acne of claims 10 furthercomprising pharmaceutically acceptable excipients selected from thegroup consisting of water, glycerin, gels, oils, waxes, emollients,cleansers, fragrances, antiseptics, anesthetics, seaweed powder, coralpowder, hydrogen peroxide, enzyme gel, jojoba oil and boric acid. 12.The therapeutic composition of claim 11 wherein said water is selectedfrom the group consisting of water for injection, irrigation water,distilled water, deionized water, chamomile water and calendula water.13. A therapeutic composition comprising: from 0.8 to 1.5 parts ofsubstantially pure Spongilla powder, and at least one additionalexcipient selected from the group consisting of from 0.1 to 0.5 parts ofgreen seaweed powder, from 0.1 to 0.5 parts of white seaweed powder,from 0.1 to 0.5 parts of coral powder, from 0.1 to 0.5 parts of Plantainpowder, from 0.5 parts to 5 parts of 0.1% to 10% hydrogen peroxide, from0.5 parts to 5 parts of 0.1% to 10% boric acid, from 0.5 parts to 5parts of enzyme gel, from 0.5 parts to 10 parts of jojoba oil, and from0.5 parts to 5 parts of water.
 14. The therapeutic composition of claim13 comprising 1.5 parts of substantially pure Spongilla powder, 0.2parts of green seaweed powder, 1.0 milliliter of 3% hydrogen peroxide,and 4.0 milliliters of 5% boric acid.
 15. The therapeutic composition ofclaim 13 comprising a skin resurfacing composition comprising 0.8 partsof substantially pure Spongilla powder, 0.2 parts of Plantain powder,and 2.5 parts of enzyme gel.
 16. The therapeutic composition of claim 13comprising 1.0 parts of substantially pure Spongilla powder, 0.3 partsof white seaweed powder, 0.2 parts of coral powder, and 5.0 milliliterof 3% hydrogen peroxide.
 17. The therapeutic composition of claim 13comprising 1.2 parts of substantially pure Spongilla powder, 0.2 partsof white seaweed powder, 0.1 parts of green seaweed powder, 5.0milliliters of 3% hydrogen peroxide.
 18. The therapeutic composition ofclaim 13 comprising 1.2 parts of substantially pure Spongilla powder,0.2 parts of white seaweed powder, 0.1 parts of coral powder, 4.0milliliter of 3% hydrogen peroxide, and 2 parts of 2% boric acid. 19.The therapeutic composition of claim 13 comprising 1.2 parts ofsubstantially pure Spongilla powder, 0.2 parts of white seaweed powder,5.0 milliliters of chamomile or calendula water.
 20. The therapeuticcomposition according to claim 13 comprising 1 part substantially pureSpongilla powder and 2 parts 3% hydrogen peroxide.
 21. The therapeuticcomposition according to claim 13 comprising 5 parts substantially pureSpongilla powder, 5 parts 3% hydrogen peroxide, and 5 parts of 2% boricacid.
 22. The therapeutic compositions according to any one of claims 10through 21 further comprising USFDA approved packaging, labels anddirections for use.